CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lantidra (donislecel-jujn) (Intravenous) — Coverage Criteria

Coverage criteria and administration requirements for Lantidra (donislecel-jujn) intravenous islet cell infusion for type 1 diabetes across Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLantidra (donislecel-jujn) (Intravenous) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization for Lantidra; coverage allows 1 infusion with up to 2 renewals (maximum 3 lifetime doses) and requires documentation of age, vaccination status, endocrinology involvement, transplant center, crossmatch results, C-peptide, and planned immunosuppression and monitoring.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

up to 3doses per lifetime

18-75age eligibility

1e6max EIN per bag

J3590HCPCS

E10.8,E10.9covered ICD-10

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Coverage Criteria for Lantidra (donislecel-jujn)

Initial and Renewal Coverage Criteria

Covered when ALL of the following are met

General eligibility: Patient age 18-75; up to date with all vaccinations prior to initiating therapy; prescribed by or in consultation with an endocrinologist; infusion performed at University of Illinois Hospital or a manufacturer‑approved transplant center of excellence; for Medicaid requests only, product enrolled in the CMS Medicaid Drug Rebate Program.

Universal clinical criteria: No active infection (including clinically important localized infections); will not receive live vaccines during immunosuppression; will be clinically monitored for malignancy (including skin cancer) during treatment; no history of prior portal vein thrombosis (excludes thrombosis limited to second‑ or third‑order portal vein branches); no history of liver disease or renal failure and not a prior renal transplant recipient; no concomitant disease or condition (including pregnancy) that contraindicates infusion or immunosuppression; excludes patients with advanced cardiac disease, BMI >27 kg/m2, C‑peptide >0.3 ng/mL on stimulation, insulin requirement >0.7 IU/kg/day, HbA1c >12%, or unstable serious psychiatric disorder (schizophrenia, bipolar disorder, major depression).

Medicare members who received the medication within the past 365 days are not subject to step therapy requirements.

Type 1 diabetes indication-specific: Confirmed diagnosis of Type 1 diabetes mellitus for >5 years; patient unable to approach target HbA1c because of current repeated severe hypoglycemia despite intensive diabetes management (including adjustment of insulin dosing, multiple daily glucose measurements, diet/exercise modification, and HbA1c monitoring); documented at least one episode of severe hypoglycemia in the past 3 years (required assistance of another person with either blood glucose <50 mg/dL or prompt recovery after carbohydrate/IV glucose/glucagon); reduced awareness of hypoglycemia (absence of adequate autonomic symptoms at <54 mg/dL); patient will receive concomitant immunosuppression; patient is T‑ and B‑cell crossmatch negative.

There is no evidence of benefit for patients whose diabetes is well controlled with insulin therapy or who can prevent repeated severe hypoglycemia via intensive management.

Renewal criteria: Patient continues to meet the universal and indication‑specific criteria; remains adherent and tolerant to concomitant immunosuppression; absence of unacceptable toxicity (examples: severe infections, portal vein thrombosis, portal hypertension, islet graft rejection); a second infusion may be performed for failure to achieve insulin independence within 1 year (or loss of independence within 1 year after a prior infusion); a third infusion may be performed under the same criteria; maximum of 3 infusions per lifetime.

No data regarding effectiveness or safety for >3 infusions.

Requests will be denied for patients with contraindicating clinical conditions. Denied populations include those with advanced cardiac disease (e.g., myocardial infarction, heart failure), BMI >27 kg/m2, a C‑peptide >0.3 ng/mL on stimulation testing, an insulin requirement >0.7 IU/kg/day, HbA1c >12%, or an unstable serious psychiatric disorder (schizophrenia, bipolar disorder, or major depression not controlled on medication). Additional exclusions include active infection, history of liver disease or renal failure or prior renal transplant, pregnancy, prior portal vein thrombosis beyond second‑ or third‑order branches, or other concomitant conditions that contraindicate infusion or immunosuppression.

Administration is not supported for patients whose diabetes is well‑controlled with insulin therapy or for patients with hypoglycemia unawareness who are able to prevent repeated severe hypoglycemic events through intensive diabetes management (adjusting insulin dosing, frequent glucose monitoring, diet/exercise modification, and HbA1c monitoring). The policy notes there is no evidence of benefit for Lantidra in these populations.

Coding and Clinical Thresholds

HCPCSHCPCS

J3590

Unclassified biologics

NDCNDC

73539-0001-xx

NDC for Lantidra 1000 mL infusion bag (supplied volume 400 mL)

Covered Diagnosis CodesICD-10Covered

E10.8	Type 1 diabetes mellitus with unspecified complications
E10.9	Type 1 diabetes mellitus without complications

inv-07: BMI — exclusion threshold displayed as key/value

BMI exclusion threshold> 27 kg/m2

ContextBMI >27 kg/m2 listed among populations not approved due to increased risks or lack of efficacy

ApplicationMeasured as part of universal eligibility screening prior to approval

inv-08: C-peptide — exclusion threshold displayed as key/value

C‑peptide exclusion threshold> 0.3 ng/mL (any C‑peptide >0.3 ng/mL by glucagon stimulation)

ContextSpecified as C‑peptide response to glucagon stimulation; detectable or higher levels exclude treatment

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required and Lifetime Dose Limit

Prior authorization is required. Coverage is provided for 1 infusion (dose) and may be renewed up to two times for a maximum of 3 lifetime doses. Requests must document the timing of prior doses and indicate whether this is an initial, second, or third infusion.

Authorization length: 1 dose per approval; renewals: up to 2 (maximum 3 lifetime doses).
Renewal rationale must reference failure to achieve or loss of insulin independence within 1 year of prior infusion when applicable.

Step Therapy

Step Therapy Exemption for Recent Recipients

Medicare members who have received this medication within the past 365 days are exempt from any Step Therapy requirements.

Exemption applies only to Medicare members with documented receipt of the medication within prior 365 days.

Background and Indication

Lantidra (donislecel‑jujn) is an allogeneic islet cell therapy indicated for adults with Type 1 diabetes who continue to experience repeated severe hypoglycemia despite intensive diabetes management. Clinical evidence is limited and derived from small open‑label studies; risks observed include procedural and immunosuppression‑related adverse events. Treatment requires concomitant immunosuppression, confirmation of T‑ and B‑cell crossmatch negativity, and care at an approved transplant center of excellence.

Definitions and Dose Metrics

inv-16: Severe hypoglycemia — definition and clinical thresholds

DefinitionSevere hypoglycemia: an event requiring assistance of another person with symptoms compatible with hypoglycemia and associated with either blood glucose <50 mg/dL (2.8 mmol/L) or prompt recovery after oral carbohydrate, IV glucose, or glucagon administration.

Reduced awareness (related)Absence of adequate autonomic symptoms at capillary glucose <54 mg/dL (3 mmol/L), used to document reduced hypoglycemia awareness.

Documentation windowAt least one episode of severe hypoglycemia must be documented within the past 3 years for indication-specific eligibility.

inv-17: Equivalent Islet Number (EIN) — dose metric, recommended minimums and max per bag

Dose metricEquivalent Islet Number (EIN)

Recommended minimum initial dose

Documentation Required

Required Clinical Documentation for Authorization

Provide all of the following clinical documentation with the prior authorization request. Incomplete documentation may result in denial or delay.

Demographics and payer/member information (including indication of Medicare status if applicable).
Clinical indication and diagnosis (confirmed Type 1 Diabetes Mellitus ≥5 years when applicable) with relevant supporting notes.
Documentation of prior therapies and diabetes management efforts (e.g., insulin regimens, frequency of glucose monitoring, education efforts, evidence of repeated severe hypoglycemia and reduced hypoglycemia awareness where applicable).
Vaccination status showing patient is up to date with vaccinations prior to initiating therapy.
Specialist documentation: prescription by or consultation with an endocrinologist.
Treatment site documentation: planned infusion at University of Illinois Hospital or manufacturer-approved transplant center of excellence.
Transplant/infusion procedural plan including infusion via hepatic portal vein, planned dose (EIN/kg), peri-procedural antibiotic prophylaxis, portal pressure and portal vein thrombosis monitoring, and hospitalization plan (minimum 24 hours post-infusion).
Immunologic and laboratory data: T- and B-cell crossmatch negative; C-peptide and insulin requirement data if relevant; HbA1c; relevant labs showing absence of active infection, liver disease, renal failure, or prior portal vein thrombosis (exclude second- or third-order branch thrombosis per policy note).
Concomitant immunosuppression plan and documentation of ability to tolerate and adhere to immunosuppression (agents to be used and monitoring plan).
For Medicaid requests: documentation of active enrollment in the CMS Medicaid Drug Rebate Program.
If request is for a renewal (second or third infusion): documentation that patient continues to meet universal and indication-specific criteria, remains adherent/tolerant to concomitant immunosuppression, and lacks unacceptable toxicity (e.g., no severe infections, portal vein thrombosis, portal hypertension, or islet graft rejection).
For denials/contraindications: documentation that patient does NOT have contraindicating conditions (e.g., active infection, pregnancy or other conditions that contraindicate infusion/immunosuppression, advanced cardiac disease, BMI >27 kg/m2, C-peptide >0.3 ng/mL, insulin requirement >0.7 IU/kg/day, HbA1c >12%, unstable major psychiatric disorder).